FDA Adverse Event Injury Summary report: N

ANIMAS INSULIN INFUSION PUMP

MDR report key: 1202751 · Received October 15, 2008

Report

Report Number: 2531779-2008-00698
Event Type: Injury
Date Received: October 15, 2008
Date of Event: September 14, 2008
Report Date: September 14, 2008
Manufacturer: ANIMAS CORP.
Product Code: LZG
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE TOTAL DAILY INSULIN DOSE WAS REVIEWED AND CORRECTLY REFLECTED THE PROGRAMMED BASAL RATES. NO ALARMS INDICATING MALFUNCTIONS WERE RECORDED. THE PUMP WAS TESTED ON A 29 HOUR FLOW TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATION. THERE WAS NO FUNCTIONAL DEFECT FOUND WITH THE PUMP. THE PISTON CAP WAS MISSING IN THE CARTRIDGE COMPARTMENT. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A SCRATCHED DISPLAY SCREEN, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION.

Additional Manufacturer Narrative · 1

THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. THE PATIENT HAS CONTINUED TO USE THE PUMP WITH NO REPORTED SUBSEQUENT EVENT. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

Description of Event or Problem · 1

PATIENT'S DAUGHTER REPORTS ER TREATMENT FOR A LOW BLOOD GLUCOSE LEVEL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ANIMAS INSULIN INFUSION PUMP	INSULIN FUSION PUMP	LZG	ANIMAS CORP.	ANIMAS 2020

Patients

Seq	Age	Sex	Outcome	Treatment
1	60 YR		Hospitalization